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Completed

NCT Number: NCT03997708

A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms

Irritable Bowel Syndrome (IBS) is a common functional bowel disorder characterized by absence of any organic cause. The vast majority of patients associate their symptoms with specific food consumption, creating the need for developing a new therapeutic approach based on altering the dietary habits. The aim of the study focuses in the comparison of the efficacy of two dietary patterns, the adjusted to the Mediterranean Diet Low FODMAP Diet (MED-LFD) and the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS.

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon University General Hospital

Athens, 12462, Greece

About this study

Irritable Bowel Syndrome (IBS) is a functional bowel disorder. Patients associate their symptoms with specific foods consumption, creating the need for developing a new therapeutic approach based on altering the dietary intake of these patients. Low FODMAP Diet is often used as a first-line treatment based on observations showing that short-chain carbohydrates are not adequately absorbed in the small intestine and exacerbate the symptoms of IBS. Additionally, the Mediterranean diet is a cultural heritage representative of all the countries surrounded by the Mediterranean Sea, described as a diet rich in herbal foods (cereals, fruits, vegetables, legumes, nuts, olives), with olive oil as the main consumption of fats, high to moderate consumption of fish and seafood, moderate consumption of eggs, poultry, dairy products and alcohol and low consumption of red meat. On the other hand, the nutritional recommendations of British National Institute for Health and Care Excellence (NICE) managing IBS were created on the grounds of systematic reviews and are based on dietary and lifestyle modifications about caffeine, alcohol, fizzy drinks, fiber, resistant starch, fruits, sorbitol, oat and linseed consumption, meal patterns, probiotics and physical activity.

The direct aim of the study is to compare the efficacy of two dietary patterns, the MED-LFD and the nutritional recommendations of NICE managing IBS. Efficacy will be assessed based on the severity of symptoms. Additionally, possible improvements in quality of life and relief of symptoms between the two groups will be evaluated. Finally, the collected fecal samples will be used to assess the effect of each intervention on gut microbiota.

The sample was calculated to 108 participants with prespecified statistical power 80%, level of significance α=0.05 and 10% adjustment for non-compliance in each group to detect an increase in the primary outcome measure (standard deviation of outcome=60). The above hypothesis of the means was based in the meta-analysis of Peter Varju, et al. 2017. Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fulfillment of the Rome IV criteria for IBS (IBS-D, IBS-M, IBS-U)
  • Provision of written informed consent.
  • Commitment of availability throughout the study period.
  • IBS-SSS > 175

Exclusion criteria

  • Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).
  • Pregnancy.
  • Breastfeeding.
  • IBS-C (Bristol Scale type 1 - 2)

Treatment and study plan

Med-LFD

Other

All participants of this group at phase 1 (elimination phase), will initially follow the Med- LFD (2-6 weeks). At phase 2 (reintroduction phase), patients will gradually reintroduce foods rich in FODMAPs (6-8 weeks) and test their tolerance. At phase 3 (maintenance phase), following the reintroduction of foods rich in FODMAPs, patients will follow an individualized diet based on their personal tolerance (a combination of high and low FODMAPs).

Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS

Other

All participants of this group will be informed to follow a diet based on the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) for Managing IBS for 4 weeks.

Primary outcomes

  1. Change of symptoms severity pre and post intervention using a specialized questionnaire.

    Time frame: Baseline, 4 - 8 weeks and 6 months post intervention

    IBS- SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS) with total scores ranging from 0 to 500, with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.

Secondary outcomes

  1. Assessment of IBS related quality of life with a specialized questionnaire pre and post intervention between groups.

    Time frame: Baseline, 4 - 8 weeks and 6 months post intervention

    IBS-QOL - a measure that assesses the degree to which IBS interfered with quality of life over the past 30 days. It is a self-report quality of life measure, which includes domains such as dysphoria, interference with activity, body image, health worry, food avoidance, social relation, sexual and relationship issues. Each of them is rated based on the Likert scale from 1 to 5, the higher the score the lower the quality of life is. The overall score ranges between 34 - 170. A decrease of 10 points or more is a significant improvement.

  2. Assessment of general quality of life pre and post intervention between groups

    Time frame: Baseline, 4 - 8 weeks and 6 months post intervention

    12-Item Short Form Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective, covering the eight domains of health outcomes: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional & mental health. The items are weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on the questions that range from 0 to 100, with higher score indicating better health.

  3. Adequate relief of symptoms after the intervention.

    Time frame: Once per week

    Adequate relief (IBS-AR) is a single item questionnaire of pain and discomfort. It poses the question "Over the past week have you had adequate relief of your IBS symptoms?", with a positive or negative answer. Adequate relief is defined as 50% positive answers within the study period, for the purposes of the trial.

  4. Assessment of symptoms burden in general pre and post intervention.

    Time frame: Baseline, 4 - 8 weeks and 6 months post intervention

    The GSRS questionnaire was originally developed for dyspeptic patients but was later validated in patients with IBS. The GSRS is a 15-item questionnaire designed to assess common gastrointestinal symptoms. The questionnaire has five subscales, reflux, diarrhea, constipation, indigestion, and abdominal pain, with subscale scores ranging from 1 (no discomfort) to 7 (severe discomfort). Higher scores represent higher symptom burden.

  5. Assessment of anxiety and depression disorders pre and post intervention.

    Time frame: Baseline, 4 - 8 weeks and 6 months post intervention

    The Hospital Anxiety and Depression Scale (HADS) questionnaire is used for the assessment of anxiety and depression symptoms. It's a 14-item scale with seven items for each subscale, anxiety (HADS-A) and depression (HADS-D). Each item is scored on a response scale with four alternatives, ranging between 0 and 3. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A final score of 0-7 on each scale indicates that the patient has no symptoms, a score of 8-10 indicates mild symptoms while a score ≥11 indicates severe symptoms of anxiety and depressive disorders.

  6. Evaluation of the effect of interventions on gut microbiota composition between groups.

    Time frame: Baseline, 2 weeks and 6 months post intervention

    Fecal samples will be collected from each participant and stored at -80°C.

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Collaborators

  • Department of Gastroenterology, Central Clinical School, Monash University

Registry information

Official study title

Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs NICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 25, 2019
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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